m. pharm (pharmacology) - anurag.edu.in

ACADEMIC REGULATIONS, COURSE STRUCTURE

AND DETAILED SYLLABUS

FOR

MASTER PHARMACY TWO YEAR POST GRADUATE COURSE

(Applicable for the batches admitted from 2012-2013)

ANURAG GROUP OF INSTITUTIONS

(AUTONOMOUS)

SCHOOL OF PHARMACY

Venkatapur, Ghatkesar, Hyderabad – 500088

M. Pharm (Pharmacology)

2012-2013 2

Academic Regulations for M. Pharm (Regular) Degree Course

(Effective for the students admitted into I year from the Academic Year 2012-2013 onwards)

The M.Pharm Degree of Jawaharlal Nehru Technological University

Hyderabad shall be conferred on candidates who are admitted to the program and

fulfill all the requirements for the award of the degree.

1.0 ELIGIBILITY FOR ADMISSIONS:

Admission to the above program shall be made subject to the eligibility,

qualifications and specialization prescribed by the university from time to

time.

Admissions shall be made on the basis of merit rank obtained by the

qualifying candidate at an Entrance Test conducted by the University or on the

basis of any other order of merit approved by the University, subject to

reservations prescribed by the university from time to time.

2.0 AWARD OF M.PHARM DEGREE:

2.1 A student shall be declared eligible for the award of the M.Pharm degree, if

he pursues a course of study and completes it successfully for not less than

two academic years and not more than four academic years.

2.2 A Student, who fails to fulfil all the academic requirements for the award of

the degree within four academic years from the year of his admission, shall

forfeit his seat in M.Pharm course.

2.3 The minimum instruction period for each semester is 90 clear instruction

days.

3.0 COURSE OF STUDY The following specializations are offered at present for the M.Pharm Course of

study.

1. Hospital and Clinical Pharmacy

2. Pharmaceutics

3. Industrial Pharmacy

4. Pharmacology

5. Pharmaceutical Analysis and Quality Assurance

2012-2013 3

4.0 ATTENDANCE:

The programs are offered on a unit basis with each subject being considered

as an unit.

4.1 A candidate shall be deemed to have eligibility to write end semester

examinations in a subject if he has put in at least 75% of attendance in the

subject.

4.2 Shortage of attendance up to 10% in any subject (i.e. 65% and above and

below 75%) may be condoned by the college Academic council on genuine

and valid reasons on representation by the candidate with supporting

evidence.

4.3 A candidate shall get minimum required attendance at least in three (3) theory

subjects in the present semester to get promoted to the next semester. In order

to qualify for the award of the M.Pharm Degree, The candidate shall

complete all the academic requirements of the subjects, as per the course

structure.

4.4 Shortage of attendance below 65% shall in no case be condoned

4.5 A stipulated fee shall be payable towards condonation of shortage of

attendance.

5.0 EVALUATION:

The performance of the candidate in each semester shall be evaluated

subject-wise, with a maximum of 100 marks for theory and 100 marks for

practical’s, on the basis of internal evaluation and End semester Examination.

For the theory subjects 60 marks shall be awarded based on the performance in

the End semester Examination, 30 marks shall be awarded based on the internal

evaluation and 10 marks for assignment.

5.1 For theory subjects, during the semester there shall be 2 midterm

examinations. Each midterm examination consists of one subjective paper and

one assignment. The subjective paper is for 30 marks with duration of 2 hours.

Subjective paper of each semester shall contain 2 parts Section-A & Section-B.

Section-A comprises of five (5) short answer type of questions. The student

has to answer all the questions from section-A. Each question carries two

marks. A total of ten marks are allocated to section-A. Section-B consists of

five (5) essay type of questions from which the student has to answer three

questions. Each question carry not more than seven (7) marks. A total of 20

marks are allocated for section-B. The questions in the first midterm

2012-2013 4

examination includes the topics of first 2.5 units while the questions in the

second midterm examination includes the topics of remaining 2.5 units. The

assignments should be submitted before the conduct of respective midterm

examinations.

The total marks secured by the student are out of 40 marks (30marks from

midterm examination and 10 marks from assignment) in an internal

examination for a subject. The average of marks secured in two midterm

examinations shall be taken as final marks. If he/she is absent for any test /

assignment, he/she are awarded zero marks for that test / assignment.

5.2 For practical subjects, 60 marks shall be awarded based on the performance in

the End Semester Examinations, 40 marks shall be awarded based on the day-

to-day performance as internal marks.

5.3 There shall be two seminar presentations during I year I semester and II

Semester. For seminar, a student under the supervision of a faculty member,

shall collect the literature on a topic and critically review the literature and

submit it to the department in a report from and shall make an oral presentation

before the departmental committee. The departmental committee consists of

Head of the department, supervisor and two other senior faculty members of

the department. For each seminar there will be only internal evaluation of 50

marks. A candidate has to secure a minimum of 50% to be declared successful.

5.4 There shall be a Comprehensive Viva-Voce in II year I Semester. The

comprehensive Viva-Voce will be conducted by a committee consisting of

Head of the Department and two Senior Faculty members of the Department.

The comprehensive Viva-Voce is aimed to assess the students’ understanding

in various subjects he/she studies during the M.Pharm course of study. The

Comprehensive viva-voce valued for 100 marks by the Committee. There are

no internal marks for the Comprehensive viva-Voce

5.5 A candidate shall be deemed to have secured the minimum academic

requirement in a subject if he secures a minimum of 40% of marks in the End

Examination and a minimum aggregate of 50% of the total marks in the End

Semester Examination and Internal Evaluation taken together.

5.6 In case the candidate does not secure the minimum academic requirement in

any subject (as specified in 4.3) he has to reappear for the End Examination in

that subject. A candidate shall be given one chance to re-register for each

subject provided the internal marks secured by a candidate are less than 50%

2012-2013 5

and he has failed in the end examination. In such case candidate must re-

register subject(s) and secure required minimum attendance. Attendance in the

re-registered subject(s) has to be calculated separately to become eligible to

write the end examination in the re-registered subject(s). The attendance of re-

registered subject(s) shall be calculated separately to decide upon the eligibility

for writing the end examination in those subject(s). In the event of taking

another chance, the internal marks and end examination marks obtained in the

previous attempt are nullified.

5.7 In case the candidate secures less than the required attendance in any

subject(s), he shall not be permitted to appear for the End Examination in that

subject(s). He shall re-register the subject when next offered.

5.8 Laboratory examination for M.Pharm courses must be conducted with two

Examiners, one of them being Laboratory Class Teacher and second examiner

shall be other Laboratory Teacher.

6.0 EVALUATION OF PROJECT /DISSERTATION WORK:

Every candidate shall be required to submit thesis or dissertation after taking

up a topic approved by the project review committee.

6.1 A Project Review Committee (PRC) shall be constituted with Principal as

chair person, Heads of all the departments which are offering the M.Pharm

programs and two other senior faculty members.

6.2 Registration of Project work: A candidate is permitted to register for the

project work after satisfying the attendance requirement of all the subjects

(theory and practical subjects).

6.3 After satisfying 6.2, a candidate has to submit, in consultation with his project

supervisor, the title, objective and plan of action of his project work to the

Departmental Committee for its approval. Only after obtaining the approval

of Departmental Committee the student can initiate the Project work.

6.4 If a candidate wishes to change his supervisor or topic of the project he can

do so with the approval of Departmental Committee. However, the

Departmental Committee shall examine whether the change of

topic/supervisor leads to a major change of his initial plans of project

proposal. If so, his date of registration for the project work starts from the

date of change of Supervisor or topic as the case may be.

6.5 A candidate shall submit status report (in a bound-form) in two stages at least

with a gap of 3 months between them.

2012-2013 6

6.6 The work on the project shall be initiated in the beginning of the second year

and the duration of the project is for two semesters. A candidate is permitted

to submit project thesis only after successful completion of theory and

practical course with the approval of PRC not earlier than 40 weeks from the

date of registration of the project work. For the approval of PRC the

candidate shall submit the draft copy of thesis to the Principal (through Head

of the Department) and shall make an oral presentation before the PRC.

6.7 Three copies of the Project Thesis certified by the supervisor shall be

submitted to the College/School/Institute.

6.8 The thesis shall be adjudicated by one examiner selected by the Institution.

For this, Chairmen, BOS of the respective departments shall submit a panel

of 5 examiners, who are eminent in that field with the help of the concerned

guide and senior faculty of the department.

6.9 If the report of the examiner is not favourable, the candidate shall revise and

resubmit the thesis, in the time frame as prescribed by PRC. If the report of

the examiner is unfavourable again the thesis shall be summarily rejected.

6.10 If the report of the examiner is favourable, viva-voce examination shall be

conducted by a board consisting of the supervisor, Head of the Department

and the examiner who adjudicated the Thesis.

The Board shall jointly report candidates work as:

A. EXCELLENT’

B. GOOD

C. SATISFACTORY

D. UNSATISFACTORY

Head of the Department shall coordinate and make arrangements for the conduct

of viva-voce examination. If the report of the viva-voce is unsatisfactory, the

candidate will retake the viva-voce examination after three months. If he fails to

get a satisfactory report at the second viva-voce examination, he will not be

eligible for the award of the degree.

2012-2013 7

7.0 AWARD OF DEGREE AND CLASS

After a student has satisfied the requirement prescribed for the completion of the

program and is eligible for the award of M.Pharm Degree he shall be placed in

one of the following three classes.

Class Awarded % of marks to be secured

First Class with Distinction 70% and above

First Class Below 70% but not less than 60%

Second Class Below 60% but not less than 50%

8.0 WITH – HOLDING OF RESULTS:

If the candidate has not paid any dues to the university or if any case of in

– discipline is pending against him, the result of the candidate will be

withheld and he will not be allowed into the next higher semester. The

issue of the degree is liable to be withheld in such cases.

9.0 TRANSITORY REGULATIONS:

Candidate who have discontinued or have been detained for want of

attendance or who have failed after having undergoing the course are

eligible for admission to the same or equivalent subjects as and when

subjects are offered, subject to 5.5 and 2.0.

10.0 GENERAL:

10.1 The academic regulations should be read as a whole for purpose of any

interpretation.

10.2 In case of any doubt or ambiguity in the interpretation of the above rules,

the decision of the Vice – Chancellor is final.

10.3 The University may change or amend the academic regulations and

syllabus at any time and the changes and amendments made shall be

applicable to all the students with effects from the date notified by the

University.

10.4 Whenever the word he, him or his occur, it will also include she, her and

hers.There shall be no transfer within the constituent colleges of Jawaharlal

Nehru Technological University.

2012-2013 8

MALPRACTICES RULES

DISCIPLINARY ACTION FOR IMPROPER CONDUCT IN EXAMINATIONS

Nature of Malpractices/Improper

conduct

Punishment

If the candidate:

1. (a) Possesses or keeps accessible in

examination hall, any paper, note

book, programmable calculators,

cell phones, pager, palm,

computers or any other form of

material concerned with or related

to the subject of the examination

(theory or practical) in which he is

appearing but has not made use of

(material shall include any marks

on the body of the candidate which

can be used as an aid in the subject

of the examination)

Expulsion from the examination hall and

cancellation of the performance in that

subject only

(b) Gives assistance or guidance or

receives it from any other

candidate orally or by any other

body language methods or

communicates through cell phones

with any candidate or persons in or

outside the exam hall in respect of

any matter.



subject only of all the candidates involved.

In case of an outsider, he will be handed

over to the police and a case is registered

against him.

2. Has copied in the examination hall

from any paper, book,

programmable calculators, palm

computers or any other form of

material relevant to the subject of

the examination (theory or

practical) in which the candidate is

appearing.



subject and all other subjects the candidates

has already appeared including practical

examinations and project work and shall

not be permitted to appear for the

remaining examinations of the subjects of

that semester/year. The hall ticket of the

candidate is to be cancelled and sent to the

controller of examinations, AGI.

3. Impersonates any other candidate

in connection with the

examination.

The candidate who has impersonated shall

be expelled from examination hall. The

candidate is also debarred and forfeits the

2012-2013 9

seat. The performance of the original

candidate who has been impersonated,

shall be cancelled in all the subjects of the

examination(including practical’s and

project work) already appeared and shall

not be allowed to appear for examinations

of the remaining subjects of that

semester/year. The candidate is also

debarred for two consecutive semesters

from class work and all semester

examinations. The continuation of the

course by the candidate is subject to the

academic regulations in connection with

forfeiture of seat. If the imposter is an

outsider, he will be handed over to the

police and a case is registered against him.

4. Smuggles in the Answer book or

additional sheet or takes out or

arranges to send out the question

paper during the examination or

answer book or additional sheet,

during or after the examination.



subject and all other subjects the candidates

has already appeared including practical


not be permitted for the remaining

examinations of the subjects of that






academic regulations in connection with

forfeiture of seat.

5. Uses objectionable, abusive or

offensive language in the answer

paper or in letters to the examiners

or writes to the examiner

requesting him to award pass

marks.

Cancellation of the performance in that

subject.

6. Refuses to obey the orders of the

Chief Superintendent/Assistant-

Superintendent/ any officer on duty

or misbehaves or creates

In case of students of the college, they shall

be expelled from examination halls and

cancellation of their performance in that

subjects and all other subjects the

2012-2013 10

disturbance of any kind in and

around the examination hall or

organizes a walk out or instigates

others to walk out, or threatens the

officer-in-charge or any person on

duty in or outside the examination

hall of any injury to his person or

to any office relations whether by

words, either spoken or written or

by signs or by visible

representation, assaults the officer-

in-charge, or any person on duty in

or outside the examination hall or

any of his relations, or indulges in

any other act of misconduct or

mischief which result in damage to

or destruction of property in the

examination hall or any part of the

college campus or engages in any

other act which in the opinion of

the officer on duty amounts to use

of unfair means or misconduct or

has the tendency to disrupt the

orderly conduct of the examination.

candidate(s) has (have) already appeared

and shall not be permitted to appear for the

remaining examinations of the subjects of

that semester/year. The candidates also are

debarred and forfeit their seats. In case of

outsiders. They will be handed over to the

police and a police case is registered

against them.

7. Leaves the exam hall taking away

answer script or intentionally tears

of the script or any part thereof

inside or outside the examination

hall.


cancellation of performance in that subject

and all the other subjects the candidates has

already appeared including practical









academic regulation in connection with

forfeiture of seat.

8. Posses any lethal weapon or

firearm in the examination hall.



2012-2013 11







debarred and forfeits the seat.

9. If student of the college, who is

not a candidate for the particular

examination or any person not

connected with college indulges in

any malpractice or improper

conduct mentioned in clause 6 to 8

Student of the college’s expulsion from the

examination hall and cancellation of

performance in that subject and all the

other subjects the candidates has already

appeared including practical examinations

and project work and shall not be permitted

for the remaining examinations of the

subjects of that semester/year. The

candidate is also debarred and forfeiture the

seat.

Person(s) who do not belong to the

College will be handed over to police and,

a police case will be registered against

them.

10. Comes in a drunken condition to

the examination hall.








semester/year.

11. Copying detected on the basis of

internal evidence, such as, during

valuation or during special

scrutiny.

Cancellation of the performance in that

subject and all other subjects the candidate

has appeared including practical

examinations and project work of the

semester/year examinations.

12. If any malpractice is detected

which is not covered in the above

clauses 1 to 11 shall be reported to

the Malpractices committee, AGI

for further action to award suitable

punishment.

2012-2013 12

M. Pharm. (Pharmacology)

Course Structure and Syllabus

I YEAR I SEMESTER

Subject

Code

Group Subject L P Credits

A41001 PCOT Modern Pharmaceutical Analytical

Techniques

3 0 3

A41002 PCOT Advanced biostatistics and research

methodology

3 0 3

A41003 PCOT Advanced Pharmacology – I 3 0 3

A41004 PCOT Pharmacokinetics and Drug Metabolism

3 0 3

A41005 PCOT Clinical Pharmacology and

Pharmacotherapeutics

3 0 3

A41201 Lab Modern Pharmaceutical Analytical

Techniques Lab

0 3 2

A41202 Lab Advanced Pharmacology - I Lab 0 3 2

A41203 Seminar - - 2

Total Credits (5 Theory + 2 Labs + Seminar) 21

II SEMESTER

Subject

Code

Group Subject L P Credits

A42001 PCOT Intellectual Property Rights & Regulatory

Affairs

3 0 3

A42002 PCOT Screening methods and clinical research 3 0 3

A42003 PCOT Advanced Pharmacology – II 3 0 3

A42004 PCOT Advanced Screening Methods &

Toxicology

3 0 3

A42005 PCOT Advances in Pharmaceutical Sciences

3 0 3

A42201

Lab Advanced Pharmacology – II

0 3 2

A42202 Lab Screening Methods in Pharmacology 0 3 2

A42203 Seminar - - 2

Total Credits (5 Theory + 2 Labs + Seminar) 21

2012-2013 13

II YEAR I SEMESTER

Subject

Code

Group Subject Name L P Credits

A43201 Comprehensive Viva - - 2

A43202 Project Seminar - I - - 2

A43203 Project Work - - 18

Total Credits 22

II YEAR II SEMESTER

Subject

Code

Group Subject Name L P Credits

A44201 Project Work 0 0 20

A44202 Project Seminar - II 0 0 2

Total Credits 22

2012-2013 14

I Year – I Sem. M.Pharmacy (PHARMACOLOGY)

(A341001) MODERN PHARMACEUTICAL ANALYTICAL

TECHNIQUES

Unit I

a. Column Chromatography: Adsorption and partition, theory, preparation,

procedure and methods of detection

b. Thin Layer Chromatography: Theory, preparation, procedures, detection of

compounds

c. Paper Chromatography: Theory, different techniques employed, filter

papers used, qualitative and quantitative detection

d. Counter – current extraction, solid phase extraction techniques, gel

filtration

Unit II

a. Gas chromatography: Introduction, fundamentals, instrumentation,

columns: preparation and operation, detection, dramatization.

b. HPLC: Principles and instrumentation, solvents and columns used,

detection and applications

Unit III

a. UV-Visible spectroscopy: Introduction, electromagnetic spectrum,

absorbance laws and limitations, instrumentation-design and working

principle, chromophore concept, auxochromes, Wood-Fisher rules for

calculating absorption maximum, applications of UV-Visible spectroscopy

b. IR spectroscopy: Basic principles-Molecular vibrations, vibrational

frequency, factors influencing vibrational frequencies, sampling

techniques, instrumentation, interpretation of spectra, FT-IR, theory and

applications

Unit IV

Mass spectroscopy: Theory, ionization techniques: electron impact

ionization, chemical ionization, field ionization, fast atom bombardment,

plasma desorption, fragmentation process: types of fission, resolution,

GC/MS, interpretation of spectra and applications for identification and

structure determination

2012-2013 15

Unit V

NMR: Theory, instrumentation, chemical shift, shielding and deshielding

effects, splitting of signals, spin-spin coupling, proton exchange reactions,

coupling constant(J), nuclear overhauser effect(NOE), 13

C NMR spectra

and its applications, 2D-NMR, COSY and applications in pharmacy

Text Books:

1. Sharma BK (2007). Instrumental Methods of Chemical Analysis. 16th ed.

Delhi: Goel Publishing House.

2. Sharma YR (2011). Organic spectroscopy. 4th ed. New Delhi: S.Chand &

Co.

3. Connors KA (2010). A Text book of Pharmaceutical Analysis. 3rd ed.

India: Wiley India .

4. Vogel AI (2009). Text book of Quantitative Chemical Analysis. 6th ed.

Delhi: Pearson.

5. Beckeet AH (2002). Stenlake J.B Practical Pharmaceutical Chemistry .

4th ed. New Delhi: CBS Publication.

6. Finar IL (2009). Organic Chemistry. 6th ed. New Delhi: Pearson.

7. William Kemp (2005). Organic Spectroscopy. New York: Palgrave.

8. Grrett DC (2007). Quantitative Analysis of Drugs. 3rd ed. New Delhi: CBS

Publishers.

9. Sethi PD (2010). Quantitative Analysis of Drugs in Pharmaceutical

Formulations . 3rd ed. New Delhi: CBS Publishers.

10. Silverstein (2010). Spectrophotometric identification of Organic

Compounds . 6th ed. New Delhi: John Wiley.

11. Seth PD (1996). HPTLC: High Performance Thin Layer Chromatography.

New Delhi: CBS publishers.

12. India. Ministry of Health and Family Welfare, Indian Pharmacopoeia

Commission (2007). Indian Pharmacopoeia. Ghazibad (Raj Nagar): Indian

Pharmacopoeia Commission.

2012-2013 16


(A41002)ADVANCED BIOSTATISTICS AND RESEARCH METHODS

Unit-I :

Developing a research question, Resources for research question,

Literature Review: Traditional Qualitative Review

Meta-Analysis—A Quantitative Review

Preparation of Research Proposal

Variables—Definition of Variable, Types of variables—Dependent and

Independent variables, Confounded variables, Measurement of variables,

Types of measurement scales and their comparison. Reliability and Validity

of Measurements.

Unit-II : Validity, Types of validity—Internal validity, Construct validity, External

validity, Threats to validity.

Control: Subject as own control (Within Subject control), Statistical control.

Unit-III:

Non-experimental Research:

Part 1—Observational, Archival and Case-Study Research: The

Hermeneutic Approach.

Observational Research: Naturalistic Observation, Participant-Observer

Research.

Archival Research: Archival Data Collection and Compilation.

Case Studies: Characteristic of Case Studies.

Non-experimental Research: Survey Research—Designing of Questionnaire,

Methods of Administration, Response Rates. Types of Samples—

Haphazard Samples, Purposive Samples, Convenience Samples and

Probability Samples.

Unit-IV :

True Experiments: Single-Factor Designs, Factors, Levels, Conditions, and

Treatments. Within-Subject Designs.

True Experiments Part-2—Factorial Designs—Main Effects, Interactions, A

Mixed Factorial Design.

2012-2013 17

Unit V :

Single-Subject Experiments: Advantages and Disadvantages.

Quasi Experiments: The differences between Quasi and True Experiments.

Design without Control Groups—Interrupted Time Series Designs and

Repeated Treatment Designs.

Text Books

1. Donald H. Mc Burney -Theresa L. White (2009). Research Methods. New

Delhi: Cengage learning India Pvt. Ltd.

2. Hooda-R.P (2000). Statistics for business and economics. 3rd ed. New

Delhi: MC. Millan Business books.

3. Tiwar N.K.,Rao G.N (2008). Biostatistics & Computer applications. Sultan

Bazar, Hyderabad, AP: Pharma Med Press.

4. Lippincot Williams (2006). Remingtons Pharmaceutical Sciences. 21st ed.

Noida, India: B.I. Publications.

5. Leon Lachman, Herbert A. Lieberman (2009):The Theory and Practice

of industrial Pharmacy ,2 nd ed, New Delhi:CBS Publishers

and Distributors.

2012-2013 18


(A41003) ADVANCED PHARMACOLOGY – I

Unit I

Molecular Basis of Drug Action

Cell Signaling and signal transduction: Cell signaling, communication

between cell and their environment, organization of signal transduction

pathways.

Cell Proliferation and apoptosis: Cell cycle, Angiogenesis, pathways of

apoptosis.

Unit-II

Drugs acting at Synaptic and neuroeffector junctional sites.

a. Autonomic & Somatic nervous systems.

b. Muscarinic receptor agonists & antagonists.

c. Anticholinesterases.

d. Agents acting at Neuro Muscular Junction and autonomic

ganglia.

e. Sympathomimetic drugs, Catecholamines and Adrenergic

antagonists.

Unit-III

Drugs acting on the Central Nervous System

a. Neurotransmission and CNS.

b. Pain and the molecular basics drug of action

c. Drugs used in the treatment of Neuropsychatric diseases

1. Anxiety & Psychosis

2. Depression & Mania

3. Migraine

d. Drugs used in the treatment of Neurodegenerative diseases

1. Parkinson’s Disease

2. Epilepsy

3. CNS degenerative disorders

e. Drug addiction, dependence and abuse.

Unit-IV

Drugs affecting renal and cardiovascular function.

a. Diuretics

b. Renin & Angiotensin

c. Drugs used in the treatment of

2012-2013 19

1. Myocardial Ischemia

2. Hypertension

3. CHF

4. Hyperlipidemia

Unit-V

a. Growth factors

b. Anticoagulants, Thrombolytics & antiplatelet drugs.

c. Agents that affect bone mineral homeostasis

d. Ocular pharmacology

e. Dermatological pharmacology, Vitamins & Chelating agents

Text Books

1. George M. Brenner., Craig Stevens. (2012). Pharmacology. 4th ed.

Oxford, USA: Elsevier Limited.

2. Joel G. Hardman., Lee E. Limbard & Alfred Goodman Gilman (2001). The

Pharmacological Basis of Therapeutics. 10th ed. New Delhi: The Mcgraw-

Hill Companies.

3. Pillay, V.V. (2008). Modern Medical Toxicology. 3rd ed. New Delhi:

Jaypee Brothers.

4. Rang, H.P. & Dale, M.M. (2012). Rang and Dale’s Pharmacology. 7th ed.

Philadelphia, USA: Elsevier.

5. Sahil Bhattacharya., Parantapa Sen& Arunabha Ray (2009).

Pharmacology. 2nd ed. Philadelphia, USA: Elsevier.

6. Satoskar, R.S., Nirmala N. Rege & Bhandarkar, S.D. (2011).

Pharmacology and Pharmacotherapeutics.. 22nd ed. Mumbai: Popular

Prakashan Pvt. Ltd.

7. Sharma, H.L. & Sharma, K.K. (2007). Principles of Pharmacology. India:

Paras.

8. Tripathi, K.D. (2010). Essentials of Medical Pharmacology. 6th ed. New

Delhi: Jaypee Brothers Medical Publishers Pvt. Ltd.

2012-2013 20


(A41004) Pharmacokinetics and Drug metabolism

Unit - I

Drug Absorption: Gastrointestinal, percutaneous and rectal kinetics and factors

affecting drug absorption.

Unit - II

Drug Distribution: Plasma protein binding – factors affecting plasma protein

binding – Tissue binding – transfer of drugs through biological barriers their

therapeutic implication in drug action.

Unit - III

Elimination of drugs: Reaction of the body to foreign substances.

Biotransformation of drugs, phase I and phase II metabolic reactions.

Excretion: Concept of renal clearance of drugs – biological half – life.

Unit - IV

Bioavailability of drug products: Bioavailability Tests, Bioequivalence studies,

Objectives & types of Bioequivalence study protocol as per FDA guidelines.

Unit - V

Drug interaction: Pharmacokinetic, Pharmacodynamic drug interactions, Food

drug and drink interactions food –herb drug interaction.

Text books

1. Gibaldi, M. (2010). Biopharmaceutics and Clinical Pharmaceutics. 4th ed.

Hyderabad: Pharmamed Press.

2. Ivory H. Stockley. (1996). Drug Interactions. 4th ed. London: Pharmaceutical

Press.

3. Kamalesh Kohli., Madhur Gupta & Sheela Tejwani (2006). Contemporary

Perspectives on Clinical Pharmacotherapeutics. 1st ed. USA: Elsevier.

4. Petter Jenner & Bernard Testa (1981). Concepts in Drug Metabolism.

Illustrated ed. New York: Dekker Publishers.

5. Robet E. Notari (2010). Biopharmaceutics and Clinical Pharmacokinetics. 4th

ed. New York: Marcel Dekker, Inc.

6. Roger Walker & Cate Whittlesea. (2010). Clinical Pharmacy and

Therapeutics. 4th ed. USA: Elsevier.

2012-2013 21


(A41005) CLINICAL PHARMACOLOGY & PHARMACOTHER

APEUTICS

Unit-I

A. Clinical Pharmacokinetics and Tocicokinetics

i) Dose – response in man

ii) Influence of renal and hepatic disease on

Pharmacokinetics

iii) Therapeutics drug monitoring

iv) Population Pharmacokinetics.

v) Total parenteral nutrition

vi)

Unit-II

Adverse Drug Reactions, Drug Interactions and ADR monitoring.

Unit-III

Pathophysiology and drug therapy of the following disorders.

Schizophrenia, anxiety, depression, epilepsy, Parkinson’s, alzheimer’s

diseases, migraine, hypertension, angina pectoris, arrhythmias,

atherosclerosis, myocardial infarction, TB, leprosy, leukemia, solid

tumors, lymphomas, psoriasis, respiratory, urinary, g.i. tract infections,

endocarditis, fungal and HIV infection, rheumatoid arthritis, glaucoma,

menstrual disorders, menopause, systemic lupus.

Unit-IV

Drug therapy in

A. Geriatrics

B. Pediatrics

C. Pregnancy & Lactation.

Unit-VI

Pharmacogenetics: Inter-racial and individual variability in drugs

metabolism.

2012-2013 22

Textbooks

1. Barar FSK (2000). Essential Of Pharmacotherapeutics-Illustrated.

3rd ed. New Delhi: S Chand.

2. Bennett PN Brown MJ (2005). Clinical Pharmacology. 9th ed.

USA: Elsevier.

3. Eric T Herfindal Dick R Gourley & Linda Lloyd Hart (2011).

Clinical Pharmacy and Therapeutics. 4th ed. Gurgaon: Wolters

Kluwer.

4. Goldstein A Aronow L & Kolman SM (1978). Principles of Drug

Action. 2nd ed. New York: Wiley And Sons

5. Ivory H Stockley (1996). Drug Interactions. 4th ed. London:

Pharmaceutical Press

6. Joel G Hardman Lee E Limbard & Alfred Goodman Gilman (2001).

The Pharmacological Basis Of Therapeutics. 10th ed. New Delhi:

Mcgraw-Hill Companies.

7. Joseph T Dipiro Robert L Talbert & Gray Yee (2001).

Pharmacotherapy: A Pathophysiologic Approach. 8th ed. New

Delhi: Mcgraw-Hill Companies

8. Kamalesh Kohli., Madhur Gupta & Sheela Tejwani (2006).

Contemporary Perspectives on Clinical Pharmacotherapeutics. 1st

ed. USA: Elsevier.

9. Rang H P & Dale M M (2012). Rang and Dale’s Pharmacology. 7th

ed. USA: Elsevier.

10. Roger Walker & Cate Whittlesea (2010). Clinical Pharmacy And

Therapeutics. 4th ed. USA: Elsevier.

11. Satoskar R S Nirmala N Rege & Bhandarkar, S.D. (2011).

Pharmacology And Pharmacotherapeutics. 22nd ed. Mumbai:

Popular Prakashan Pvt Ltd.

2012-2013 23


(A41201) Modern Pharmaceutical Analytical Techniques Lab

1. Formulation and evaluation of oral disintegrating tablets (1 Expts)

2. Formulation and evaluation of topical gels (2 Expts)

3. Formulation and evaluation of injections (2 Expts)

4. Formulation and evaluation of emulsion (2 Expts)

5. Formulation and evaluation of suspension. (2 Expts)

6. Formulation and evaluation of rectal suppositories. (1 Expts)

7. Formulation and evaluation of enteric coating tablets. (1 Expts)

8. Comparision of dissolution release profile of two marketed products (2 Expts)

2012-2013 24


(A41202) Advanced Pharmacology - I Lab

1) DRC of Acetylcholine using frog’s rectus abdominus muscle.

2) Effect of Neostigmine on DRC of Acetylcholine using frog’s rectus

abdominus muscle.

3) Effect of d-tubocurarine on DRC of Acetylcholine using frog’s rectus

abdominus muscle.

4) Determination of unknown concentration of given drug by Interpolation

Bioassay using frog’s rectus abdominus muscle.

5) Determination of unknown concentration of given drug by Three Point


6) Determination of unknown concentration of given drug by Four Point


7) Cumulative Dose Response Curve.

8) Effect of Electrolytes on isolated perfused heart of frog.

9) Effect of parasympathomimetics and parasympatholytics on isolated

perfused heart of frog.

10) Effect of sympathomimetics and sympatholytics on isolated perfused heart

of frog.

11) Effect of cardiotonic on hypodynamic isolated perfused heart of frog.

12) Effect of Acetylcholine,Atropine and Physostigmine on ciliary movement

of frog’s Buccal preparation.

13) Effect of Lignocaine on frog’s Sciatic nerve preparation.

14) Effect of Mydriatic activity on rabbit eye using light reflex method.

15) Study of various routes of administration for drug action.

16) Effect ofCNS depressant on mice using Actophotometer.

17) Effect of Diazepam on muscle coordination on rats using Rotorod

apparatus.

18) Study of analgesic action of Morphine on mice by Hot plate, Tail clip and

Tail Immersion method.

19) Effect of Anti-Depressant activity of Caffeine on mice by Tail

suspension method.

20) Effect of Diazepam on rightining effects of rats.

21) Determination of various anaesthetic actions.

2012-2013 25

I Year – II Sem. M.Pharmacy (PHARMACOLOGY)

(A42001) INTELLECTUAL PROPERTY RIGHTS AND DRUG

REGULATORY AFFAIRS

Intellectual Property Management:

Unit I : Types of IP, definition, scope, objectives Patents, types, contents of

patent, claims and types of claims, key terminology used in patents

(Application, examiner, prior art, priority, specifications, provisional and

non-provisional applications, claims, applicant, assignee, inventor,

anticipation, obviousness, infringement and invalidation).

Unit II : Filing process, provisional and non-provisional applications, PCT filing

process, Advantages, Patentability requirement: (Novelty, Utility, non-

obviousness, enablement and best mode), Understanding on

infringement, invalidation and litigations

Unit III : Indian patent act and post 1995 amendments US and European patent

act Trademarks, copyrights, designs International conventions, GATT,

TRIPS, Paris convention, Patent cooperation treaty.

Regulatory Affairs:

Unit IV: National drug regulatory requirements, national drug policy, Drugs and

Cosmetics Act and its amendments, over view of schedules, details of

schedule M, Schedule Y. US FDA, orange book, FDA guidelines on

IND, new drug approvals (NDA), ANDA approvals, SUPAC changes

and understanding on 505 (b) (2) applications.

Unit V : Office of generic drugs, recommendations on dissolution and bio-

equivalence requirements, types of ANDA filing (P I, II, III and IV)

PIV ANDA filing and process involved till the approval Exclusivities

(NCE, NS, NP, NDF, PED, ODE, PC exclusivity) European

regulatory agency, types of filing process (Centralized, de-centralized,

RMS countries), SPCs, SPC exclusivities, data exclusivities, WHO,

WIPO, ICH objectives and guidelines.

2012-2013 26

Text Books:

1. Guarino (2002). New drug approval process. 3rd ed. New York: Marcel

Dekker Publication.

2. Commercial’s, “Manual on Drugs and Cosmetics”, (2002). 2nd

ed. Delhi:

Commercial Law Publishers.

3. Vijay Malik (2006). Drugs and Cosmetics act. 11th ed. Lucknow:

Publications Eastern Book.

4. S.H. Wiling (2003). Good Manufacturing Practices for Pharmaceuticals.

2nd ed. New York.: Marcel Decker.

5. P.Das and Gokul Das., Protection of Industrial Property rights. 1st ed.

New Delhi: Ukaaz Publications.

6. S.N. Katju (2009). Hand book of Law of Drugs. 5th ed. Allahabad: Law

Publications.

7. R.A.Guarino, (2009). New Drug Approval Process. 4th ed. New York.:

Marcel Decker.

8. Original Laws. Published Government of India, Ministry of Human

Resource Development, Department of Secondary Education and Higher

Education

2012-2013 27


(A42002) PHARMACOLOGICAL SCREENING METHODS AND

CLINICAL RESEARCH

Unit I

Care Handling and breeding techniques of laboratory animals, Regulations for

laboratory animals, CPCSEA guidelines, alternatives to animal studies, Good

laboratory Practices.

Unit II

Bioassays: Basic principles of Biological standardization: Methods used in the

bio-assay of Rabbis Vaccine , Oxytocin , Tetanus Antitoxin and Diphtheria

Vaccine . Test for pyrogens.

Unit III

Toxicity tests: OECD guidelines, determination of LD50, acute, subacute and

chronic toxicity studies.

Unit IV

Organization of screening for the Pharmacological activity of new substances

with emphasis on the evaluation cardiac, psychopharmacological, anti-

inflammatory, analgesic and anti diabetic.

Unit V

Clinical evaluation of new drugs, Phases of clinical trial, protocol design, Ethics

in human research.

Pharmacovigilance: Definition, collection of data, reporting, assessment of Post

marketing surveillance, periodic safety update reports, Risk-benefit

assessment

Text Books:

1. David M, Simon D, Sylvan G (2007). Test book of clinical trials: 2 nd ed.

London: Wiley India.

2. Giovanna D, Ignazio GH (2001). Principles of clinical research: 1st ed.

Philadelphia: Routledge publications.

3. Robert A, Turner PH (1965). Screening methods in Pharmacology. 1st ed.

London: Academic Press publications.

4. Vogel HG. Vogel WH (2006). Drug discovery and Evaluation-

Pharmacological Assays. 3rd ed. Heidelberg New York: Springer Verlag

publications.

2012-2013 28


(A42003) Advanced Pharmacology – II

Unit I

Autacoids: Drugs therapy of Inflammation.

A. Histamine, Bradykinin & their antagonists

B. Eicosanoids & PAF (Platelet Activating Factors)

C. Anti-inflammatory, analgesic & antipyretic agents.

D. Anti-asthamatic agents.

Unit II

Drugs affecting gastro intestinal function.

A. Agents for control of acidity and antiulcer drugs.

B. Emetics & anti emetics.

Unit III

Chemotherapy of

A. Malaria

B. Microbial infections

(i) Fluoroquinolones

(ii) Cephalosporins and others newer agents.

(iii) Antifungal & antiviral drugs including anti HIV drugs.

C. Neoplastic diseases

D. Immunomodulators & Immunosuppressive agents

Unit IV

Estrogens, Progestins and Androgens, Insulin, Oral hypoglycemic agents,

Thyroid and Anti-Thyroid agents.

Text Books

1. George M Brenner, Craig Stevens (2012). Pharmacology. 4th ed. USA:

Elsevier Limited Oxford.

2. Joel G Hardman Lee E Limbard & Alfred Goodman Gilman (2011). The

Pharmacological Basis Of Therapeutics. 10th ed. New Delhi: The

Mcgraw-Hill Companies.

3. Pillay V V (2008). Modern Medical Toxicology. 3rd ed. New Delhi:

Jaypee Brothers.

4. Rang H P Dale M M (2012). Rang And Dale’s Pharmacology. 7th ed.

USA: Elsevier.

2012-2013 29

5. Satoskar R S Nirmala N Rege Bhandarkar S D (2011). Pharmacology And

Pharmacotherapeutics . 16th ed. Mumbai: Popular Prakashan Pvt Ltd.

6. Sharma H L & Sharma K K (2007). 1st ed. Principles Of Pharmacology.

India: Paras.

7. Tripathi K D (2010). Essentials Of Medical Pharmacology. 6th ed. New

Delhi: Jaypee Brothers Medical Publishers Pvt Ltd.

2012-2013 30


(A42004) Advanced Screening Methods & Toxicology

Unit-I

a. Drug discovery process: Principles, techniques and strategies used in new drug

discovery. High throughput screening, human genomics robotics and economics

of drug discovery, Regulations, for laboratory animal care and ethical

requirements.

b. Bioassay methods for autacoids, vasopressin, oxytocin, acetylcholine,

adrenaline, insulin, d-tubocurarine, HCG, hyaluronidase, corticotrophine,

pertussis, rabbis and plague.

Unit-II

Preclinical models employed in the screening of new drugs belonging to

following categories. Antifertility agents, sympathomimetics,

parasympathomimetics, muscle relaxants (both central and peripheral), sedatives,

hypnotics, antiarrhythmic agents, cardiac stimulants, bronchodilators,

antihistaminics, eicosanoids. Antisychotic agents, antianxiety agents, nootropic

drugs , antidepressant drugs; antiparkinsonian agents, antiepileptics ; antiulcer

agents; infarction; antiatherosclerotic drug; antimalarials; anthelmintics models

for status epilepticus drugs/ cerebroventricular and other newer techniques of

drug administration and development; transgenic animals and other genetically

prone animal models.

Unit-III

Alternatives to animal screening procedures, cell-line, patch –clamp technique,

In-vitro models and screening techniques- (a) Reagent preparation, (b)

Biochemical assays, (c) Cell based assays, (d) Tissue based assays. Molecular

biology techniques, In-silico ADME modeling,

Unit-IV

Principles of Toxicology, reproductive toxicity, genotoxicity, ocular toxicity,

Test for mutagenicity, carcinogenicity, teratogenicity, special tests. Techniques

for toxicity studies in man, Toxicogenomics

2012-2013 31

Unit-V.

Poison

i. Classification of Poisoning

ii. Diagnosis of poisoning

iii. Physical signs of poisoning

iv. Principles of management of acute poisoning, treatment of poisoning

v. Common poisoning agents

Textbooks

1. Gerhard Vogel H (2002). Drug Discovery And Evaluation. 2nd ed. New

York: Springer-Verlag Berlin Heilderberg.

2. Pillay VV (2008). Modern Medical Toxicology. 3rd ed. New Delhi: Jaypee

Brothers.

3. Robert A, Turner PH (1965). Screening methods in Pharmacology. 1st ed.

London: Academic Press publications.

2012-2013 32


(A42005) Advances in Pharmaceutical Sciences

Unit-I

New Drug Discovery – Target identification, validation, Therapeutics and

development – their implications on drug discovery.

Unit-II

Overview on computer aided Drug design (CADD) including QSAR, QSPR,

Combinational Chemistry, High Throughput screening (HTS)

Molecular Basis of Drugs Action.

Drug Latentiation: Basic concepts, Prodrugs of functional groups, Bio-precursor

prodrugs, chemical delivery system.

Unit-III

Isolation and purification of protein: electrophoresis, blotting PCR, RT-PCR

techniques.

Biotechnology in Drug Discovery: Cloning of DNA, Expression of cloned DNA,

Manipulation of DNA sequence information, New Biological Targets for Drug

Development Novel Drug Screening strategies, Novel Biological Agents,

Antibodies, Antisense oligonucleotide therapy, Gene therapy, stem cells therapy,

xenotransplantation.

Unit-IV

Herbal neutraceuticals and marine products as new source for medicines.

Unit-V

Study of Advanced drugs from natural sources of following groups:

Anticancer, Anti AIDS, Hepatoprotectives, Antidiabetics, Antiarthritic,

Adaptogenic, Cardiotonic, Antipyretic, antimalarials, Diuretics, Hypnotics, Brain

Tonic, Urolithiasis, Antifilarial, Antihyperlipidemic Recent trends in study of

authentic and controversial drugs of above mentioned groups. Modern

Phytochemical screening techniques and evaluation of Herbal. Regulatory and

safety for alternative medicines. Drugs, their extracts and formulations-concept

of Reverse Pharmacognosy

2012-2013 33

Textbooks

1. Agrawal SS & Paridhavi M (2009). Herbal Drug Technology. 2nd ed.

New Delhi: Universities Press.

2. Chaterjee TK (2000). Medicinal Plants with Hepatoprotective

Properties :Herbal Options. 3 rd ed. Calcutta: Books & Allied (P) Ltd.

3. Chopra RN (1958). Indigenous Drugs Of India. 2nd ed. Kolkata: UN

Dhur & Sons

4. Eric T Herfindal Dick R Gourley & Linda Lloyd Hart (2011). Clinical

Pharmacy and Therapeutics. 4th ed. Gurgaon: Wolters Kluwer.

5. Gordon Gibson G & Paul Skett (2001). Introduction To Drug

Metabolism. 3rd ed. Great Britain: Nelson Thornes

6. Handa SS Maharaj Kaur (1996). Supplements To Cultivation And

Utilization Of Medicinal Plants. Regional Research Laboratory: CSIR.

7. Harborne AJ (1996). Phytochemical Methods-A Guide To Modern

Techniques Of Plant Analysis. 3rd ed. London: Chapman & Hall.

8. John M Beale Jr John H Block (2010). Wilson And Gisvold’s Textbook

Of Organic Medicinal And Pharmaceutical Chemistry. 12th ed. New

Delhi: Wolters Kluwer.

9. Kirtikar KR Basu BD (1996). Indian Medicinal Plants. 2nd ed.

Dehradun: International Book Distributors.

10. Manfred E Wolff (1997). Burger’s Medicinal Chemistry And Drug

Discovery. 5th ed. New York: Wiley-Interscience.

11. Murray Moo-Young, Campbell W Robinson & John A Howell (1985).

Comprehensive Biotechnology: The Practice Of Biotechnology. 1 st ed.

UK: Pergamon Publishers

12. Paul M Dewick (2009). Medicinal Natural Products: A Biosynthetic

Approach. 3rd ed. New York: Wiley.

2012-2013 34


(A42201) Advanced Pharmacology – II Lab

Introduction to experimental pharmacology

Animal handling techniques used in experimental pharmacology.

Orientation of CPCSEA guidelines and IAEC.

Demonstration of various instruments used for experimental pharmacology.

1. To study the hydrolysis of acetylcholine using anticholinesterase.

2. DRC of histamine using guinea pig ileum.

3. Effect of chlorpromazine on histamine induced contraction on guinea pig

ileum.

4. DRC of serotonin using rat fundus.

5. DRC of oxytocin using rat uteri horn.

6. DRC of acetylcholine using rat colon preparation.

7. Determination of PA2 value of chloropromazine on DRC of histamine using

guinea pig ileum.

8. Determination of unknown concentration of given drug by three point bioassay

using guinea pig ileum.

9. Determination of unknown concentration of given drug by three point bioassay

using rat uterus preparation.

10. Determination of unknown concentration of given drug by interpolation

bioassay using guinea pig ileum.

11. Recording of finger pulse of human using power lab.

12. Recording of human ECG using power lab.

13. Recording ECG of rat using power lab.

14. Recording invasive blood pressure of rats by using power lab.

15. Recording invasive blood pressure and ECG in rat by using carotid artery

cannulation.

16. Effect of sympathetic drugs on B.P of rat by using invasive method.

17. Effect of parasympathetic drugs on B.P of rat by using invasive method.

18. Effect of histamine and anti-histaminic drugs on B.P of rat by using invasive

method.

19. Effect of lignocaine on B.P of rat by using invasive method.

2012-2013 35

20. Recording invasive blood pressure and ECG in rat by using carotid artery

cannulation.

21. Screening of anti-arrhythmic drug by ECG using power lab.

22. Screening of anti-hypertensive drugs by isoproterenol induced MI using

power lab.

23. Determination of ions in urine of rat after treating with diuretics.

24. To study the effect of toxicity of narcotics on behavioural parameter by

modified Irvin method.

25. Effect of oxytocin on the isolated rat uterus muscle by three point bioassay.

26. Study of glucose lowering activity on rabbits.

27. Study of effect of various drugs on rabbit jejunum.

2012-2013 36


(A42202) Advanced Screening Methods & Toxicology Lab

1. Effect of diazepam on muscle coordination on rats/mice by traction test.

2. Effect of diazepam on rightining reflex of rats.

3. Determination of anxiogenic and anxiolytic drugs activity on mice using

elevated plus maze by video tracking system.

4. Determination of alternative behavior of drugs on mice using Y-maze by video

tracking system.

5. Effect of amnesic and nootropic drugs by step down inhibitory avoidance in

mice.

6. Effect of anticonvulsant action of drugs on MES induced convulsion in rats.

7. Effect of anticonvulsant action of drugs on PTZ induced convulsion in rats.

8. General screening methods for the anti-ulcer activity by pyloric ligation

method on rats.

9. Effect of cimetidine on ulcer protective activity in rats.

10. Effect of narcotics on mice and rats.

11. Demonstration of anti-diabetic effect of glibenclamide in STZ induced

hyperglycemic rats.

12. Determination of anti-inflammtory action of diclofenac by caragenen induced

paw odema method.

13. Determination of anti-inflammtory action of diclofenac by formalin induced

paw odema method.

14. Demonstration of anti-inflammtory action of diclofenac by granuloma pouch

technique.

15. General methods for evaluating the antimicrobial activities of

chemotherapeutic agents using disc plate, ditch plate and cup plate technique.

16. Effect of antidepressant by despaired swim test on rats.

17. Effect of anxiolytics on rats by pole climbing apparatus.

18. Anti-asthamatic action on guinea pig using histamine chamber.

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